1. Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting and apologies for absence were noted.

1.2 Chairman’s Thanks

The Chairman expressed her thanks to Dr Andrew Power who has a new appointment as medicolegal adviser to the Medical Protection Society, Edinburgh. Andrew has been a member of the New Drugs Committee (NDC) since it was formed in December 2001. He rotated from NDC to SMC in June 2006 and was appointed as NDC Co-Vice Chair in November 2006. Andrew has been a valued member of NDC and SMC as well as the SMC Executive and the Patient and Public Involvement Group (PAPIG) and his commitment and contribution to these groups has been immense.

Thanks were also made to Mrs Marie McHenery, Public Involvement Officer, who is moving on from her post. Marie has made a substantial contribution to the public involvement agenda and we are very sorry to see her go.

1.3 Welcome

The Chairman welcomed Professor Dilip Nathwani, Chairman of the Scottish Antimicrobial Prescribing Group (SAPG), who gave a presentation on the work of the group. The aim of SAPG is to improve the quality of antimicrobial prescribing and infection management (prophylaxis) in hospitals and primary care.

The Chairman thanked Professor Nathwani for his comprehensive report on the integration of antimicrobial stewardship within NHS Scotland and looked forward to receiving a further update on progress, in due course.

2. Declarations of Interest

2.1 The Chairman reminded members to declare interests in the products to be discussed and the comparator drugs as noted on the assessment reports.

3. Minutes of the Previous Meeting (05 April 2011)

3.1 The minutes of the SMC meeting held on 05 April 2011 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 tocofersolan (Vedrop®) Orphan Europe UK (No. 696/11)

The SMC advice for tocofersolan (Vedrop®), for vitamin E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region, will be published on the SMC website on Monday, 09 May 2011.

4.2 iron isomaltoside (Monofer®) Pharmacosmos UK (No. 697/11)

The SMC advice for iron isomaltoside (Monofer®), for treatment of iron deficiency anaemia in the following conditions: when oral iron preparations are ineffective or cannot be used; where there is a clinical need to deliver iron rapidly, will be published on the SMC website on Monday, 09 May 2011.

4.3 sunitinib (Sutent®) Pfizer Limited (No. 698/11)

The SMC advice for sunitinib (Sutent®), for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults, will be published on the SMC website on Monday, 09 May 2011.

4.4 ticagrelor (Brilique®) Astra Zeneca (No. 699/11)

The SMC advice for ticagrelor (Brilique®), co-administered with aspirin, for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non ST elevation myocardial infarction [NSTEMI] or ST elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG), will be published on the SMC website on Monday, 09 May 2011.

The SMC advice for quetiapine prolonged release and quetiapine immediate release (Seroquel XL® and Seroquel IR®), for the treatment of major depressive episodes in bipolar disorder, will be published on the SMC website on Monday, 09 May 2011.

Non-Submission

4.6 tadalafil (Adcirca®) Eli Lilly and Company Limited (No.710/11)

The SMC advice for tadalafil (Adcirca®), for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity, will be published on the SMC website on Monday, 09 May 2011.

Deferred Advice

4.7 Nothing to report.

Amended Advice

4.8 Nothing to report.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the previous meeting of PAPIG

The Minutes of the previous meeting, held on 05 April 2011, were noted.

6.2 Membership of PAPIG

Mrs Tunstall-James, expressed her thanks to Mrs Marie McHenery, Public Involvement Officer, for the invaluable work she has done for PAPIG to promote public involvement in SMC’s assessment process.

With the departure of Dr Andrew Power from SMC and PAPIG, the SMC Chairman is seeking to secure a replacement member on PAPIG who will represent the SMC Executive.

7. New Drugs Committee: Chairman’s Report

7.1 Appointment of a new Co-Vice Chair of the New Drugs Committee (NDC)

The NDC Chairman was pleased to announce that Mrs Alison Campbell, a Public Health Pharmacist in NHS Greater Glasgow and Clyde and current member of NDC, has been appointed Co-Vice Chair. Mrs Campbell, succeeds Dr Andrew Power, as Co-Vice Chair.

8. Chairman’s Business

Following a review, SMC has reached a decision on how to reference details of Patient Access Schemes in the SMC Detailed Advice Document. The approach, in each of the four possible PAS/SMC decision scenarios, is summarised below.

A. The Medicine is accepted for use in NHS Scotland (Patient Access Schemes Assessment Group (PASAG) accepted / SMC accepted)

When a medicine has been accepted by SMC on the basis of a PASAG-accepted scheme, the health economics section of the DAD will include reference to the Incremental Cost Effectiveness Ratio (ICER) for the medicine both with and without the PAS. The DAD will include details of whether the PAS is a simple or complex scheme and a brief description of how the scheme operates (e.g. first cycle free).

DAD section

Information included

Advice box

Unchanged from present i.e. includes statement that advice is based on PAS

Health economics

Includes details of how PAS scheme operates. Includes ICER with and without PAS

Budget impact

Includes with PAS estimates only

B. Medicine not recommended for use in NHS Scotland (PASAG accepted / SMC not recommended)

The DAD will contain only a brief description of the scheme (e.g. first cycle free). Further details on the proposed PAS, including details of the ICER and budget impact estimates both with and without PAS, will be distributed to NHS Boards in the PAS Register contained in each PAS Implementation Pack.

DAD section

Information included

Advice box

No mention of PAS

Health economics

Includes a statement that PAS was submitted and the type of scheme i.e. simple or complex.

Includes a statement that PAS was submitted and the type of scheme i.e. simple or complex. Notes PAS not recommended by PASAG and not taken into account in SMC decision. Notes that medicine has been accepted for use without the PAS.

D. Medicine not recommended for use in NHS Scotland (PASAG not recommended / SMC not recommended)

DAD section

Information included

Advice box

No mention of PAS

Health economics

Includes a statement that PAS was submitted and the type of scheme i.e. simple or complex.

NICE does not recommend everolimus as a second treatment for people with advanced renal cell carcinoma.

The Scottish Medicines Consortium (SMC) published a Statement of Advice (595/10) on this medication for this indication in March 2010. It stated that everolimus (Afinitor®) is not recommended for use within NHS Scotland. The licence holder has indicated their intention to resubmit.

There is no material difference between the recommendations of the NICE STA and the SMC.

Note: Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

NICE recommends golimumab as a possible treatment for people with psoriatic arthritis.

The Scottish Medicines Consortium (SMC) published a Statement of Advice (674/11) on this medication for this indication in February 2011. It stated that golimumab (Simponi®) is not recommended for use within NHS Scotland. The licence holder has indicated their intention to resubmit.

There is a material difference between the recommendations of the NICE STA and the SMC. NICE recommend golimumab with restrictions. The NICE STA advice is based upon the application of a Department of Health agreed Patient Access Scheme.

Note: Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

The Scottish Medicines Consortium (SMC) published a Statement of Advice (553/09) on this medication for this indication in October 2009. It stated that romiplostim (Nplate®) is accepted for restricted use within NHS Scotland for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Romiplostim is also accepted for restricted use as second line treatment for adult non-splenectomised patients where surgery is contra-indicated. Romiplostim is restricted to use in patients with severe symptomatic ITP or patients with a high risk of bleeding.

There is no material difference between the recommendations of the NICE STA and the SMC. The NICE STA advice is based upon the application of a Department of Health agreed Patient Access Scheme.

Note: Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

NICE does not recommend trabectedin taken with PLDH (which is short for pegylated liposomal doxorubicin hydrochloride) for women with relapsed platinum-sensitive ovarian cancer.

The Scottish Medicines Consortium (SMC) published a Statement of Advice (634/10) on this medication for this indication in September 2010. It stated that trabectedin (Yondelis®) is not recommended for use within NHS Scotland.

There is no material difference between the recommendations of the NICE STA and the SMC.

Note: Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

9.1.1 A declaration of interest was recorded in relation to this product/comparator drugs.

9.1.2 The Lead Assessor provided an overview of the assessment, draft advice, and expert comments. Detailed discussion followed and the group agreed that filgrastim (Zarzio®), should be accepted for use in NHS Scotland, for:

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.

Mobilisation of peripheral blood progenitor cells (PBPC).

In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.

Treatment of persistent neutropenia (ANC ≤ 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.

Filgrastim (Zarzio®) is a biosimilar product to a reference granulocyte colony stimulating factor, filgrastim (Neupogen®). The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name. Other granulocyte colony stimulating factor products are available at lower cost.

Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 May 2011.

9.2.1 Declarations of interest were recorded in relation to this product/comparator drugs. A member with a personal specific interest left the meeting for this part of the agenda.

9.2.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice, expert comments, and comments received from the company. A member of PAPIG presented a patient interest group submission from Pain Concern. A further submission was received from Action On Pain and was noted. Detailed discussion followed and the group agreed that tapentadol (Palexia® SR), should be accepted for restricted use in NHS Scotland, for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics. Its use is restricted to patients in whom morphine sulphate modified release has failed to provide adequate pain control or is not tolerated.

Results of a meta-analysis of three, 12-week studies suggest that tapentadol prolonged release has improved gastrointestinal tolerability and similar efficacy compared to another long-acting opioid included as an active control.

The manufacturer’s submission related only to the use of tapentadol prolonged release in severe chronic pain. SMC has not yet received a submission for tapentadol immediate release tablets for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics. Tapentadol immediate release tablets are not recommended for use in NHS Scotland.

Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 May 2011.

9.3.1 There were no declarations of interest recorded in relation to this product/comparator drugs.

9.3.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, and comments received from the company. A member of PAPIG presented a patient interest group submission from the National Kidney Federation. Detailed discussion followed and the group agreed that ferric carboxymaltose (Feriject®), should be accepted for restricted use in NHS Scotland, for the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. The diagnosis must be based on laboratory tests.

Its use is restricted to administration by intravenous infusion within the licensed indication in non-haemodialysis-dependent patients with chronic kidney disease. The manufacturer’s economic case did not consider the cost-effectiveness of bolus injections or use in haemodialysis patients.

9.4.1 There were no declarations of interest recorded in relation to this product/comparator drugs.

9.4.2 The NDC Chair provided an overview of the assessment, and draft advice. Detailed discussion followed and the agreed that triptorelin pamoate (Decapeptyl® SR 22.5mg), should be accepted for use in NHS Scotland, for the treatment of: patients with locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration; treatment of metastatic prostate cancer.

This new preparation of triptorelin allows 6-monthly administration (as triptorelin pamoate in a 22.5mg dose). Triptorelin 11.25mg (as acetate) is administered every 3 months and has previously been accepted by SMC. Bioequivalence of the pamoate and acetate salts has been demonstrated and the new preparation is cost neutral.

The indication for triptorelin 11.25mg formulation was re-worded in 2007 to achieve consistency Europe-wide and now reads as per the indication for triptorelin 22.5mg.

Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 May 2011.

9.5.1 There were no declarations of interest recorded in relation to this product/comparator drugs.

9.5.2 The NDC Chair provided an overview of the assessment and draft advice. Detailed discussion followed and the group concluded their advice for olmesartan medoxomil/amlodipine besilate/hydrochlorothiazide (Sevikar HCT®), as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide taken as a dual component (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single formulation (hydrochlorothiazide or amlodipine).

9.5.3 The SMC advice will be withheld pending confirmation of product availability.

9.6.1 Declarations of interest were recorded in relation to this product/comparator drugs.

9.6.2 The NDC Chair provided an overview of the assessment, draft advice, and comments received from the company. Detailed discussion followed and the group agreed that omalizumab (Xolair®), should be accepted for restricted use in NHS Scotland, in adults, adolescents (12 years of age and older) and children (6 to <12 years of age) with convincing IgE (immunoglobulin E) mediated asthma.

Use is restricted to patients who are prescribed chronic systemic steroids and in whom all other treatments have failed. The response to omalizumab treatment should be assessed in all patients at 16 weeks and treatment should be discontinued in patients who have not shown a marked improvement in overall asthma control.

SMC has previously accepted omalizumab (Xolair ®) 150mg powder and solvent for injection for restricted use in adults, adolescents and children. This submission is for a new solution for injection formulation that will replace the existing formulation. The 150mg solution for injection formulation is bioequivalent to the 150mg powder and solvent for injection formulation and costs the same. The new 75mg strength is half the cost of the 150mg injection and should eliminate wastage that occurred previously with certain doses.

Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 May 2011.

10. SMC User Group Forum (UGF)

10.1 Dr Frances Macdonald reported that the UGF were focusing on the following workstreams:

A process guidance review on SMC’s Guidance for Manufacturers;

A methods guidance review from an industry perspective;

An exploration of the potential effects that Value Based Pricing may have on the work of NICE and SMC.

The UGF will continue to report to SMC on progress.

11. Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled and noted.

12. Area Drug & Therapeutics Committee (ADTC) Issues

12.1 Nothing to update.

13. Any Other Business

13.1 SMC Masterclass for the Ethical Medicines Industry Group (EMIG)

The Ethical Medicines Industry Group (EMIG) is a trade association in the UK that represents the interests of small to medium-sized pharmaceutical companies. At EMIG’s request SMC presented a masterclass on SMC’s role, remit and assessment process to assist smaller companies who may wish to make a submission to SMC.

The Chairman participated in the masterclass and noted significant discussion on the particular challenges that small and medium companies face however delegates found the event very helpful. It is expected that future SMC masterclasses and/or ABPI training events will be open to all companies and trade associations.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 07 June 2011 at 12.30 pm (lunch from 12 noon), in Healthcare Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

NICE does not recommend everolimus as a second treatment for people with advanced renal cell carcinoma.

Guidance

Everolimus is not recommended for the second-line treatment of advanced renal cell carcinoma.

People currently receiving everolimus for the second-line treatment of advanced renal cell carcinoma should have the option to continue treatment until they and their clinician consider it appropriate to stop.

The Scottish Medicines Consortium (SMC) published a Statement of Advice (595/10) on this medication for this indication in March 2010. This stated that:

Advice following a full submission:

everolimus (Afinitor®) is not recommended for use within NHS Scotland.

Licensed indication under review: the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.

However, the manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC.

The licence holder has indicated their intention to resubmit

Access the advice of the Scottish Medicines Consortium

There is no material difference between the recommendations of the NICE STA and the SMC.

Note: Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

NICE Single Technology Appraisal Guidance No 220 Golimumab for the treatment of psoriatic arthritis

NICE recommends golimumab as a possible treatment for people with psoriatic arthritis.

Guidance1. Golimumab is recommended as an option for the treatment of active and progressive psoriatic arthritis in adults only if:

it is used as described for other tumour necrosis factor (TNF) inhibitor treatments in ‘Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis’ (NICE technology appraisal guidance 199)*, and

the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose.

The Scottish Medicines Consortium (SMC) published a Statement of Advice (674/11) on this medication for this indication in February 2011. This stated that:

Advice following a full submission:

golimumab (Simponi®) is not recommended for use within NHS Scotland.

Indication under review: Alone or in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.

Golimumab has demonstrated efficacy compared with placebo in patients with active psoriatic arthritis who have had an inadequate response to DMARDs or non-steroidal anti-inflammatory drugs (NSAIDs).

The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.

Golimumab is also licensed for use, in combination with methotrexate, for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to DMARD therapy including methotrexate has been inadequate and in the treatment of severe, active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. SMC cannot recommend the use of golimumab in these indications as they were not included in the manufacturer’s submission to SMC.

The licence holder has indicated their intention to resubmit.

Access the advice of the Scottish Medicines Consortium

There is a material difference between the recommendations of the NICE STA and the SMC. NICE recommend golimumab with restrictions. The NICE STA advice is based upon the application of a Department of Health agreed Patient Access Scheme.

Note: Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

NICE Single Technology Appraisal Guidance No 221 – Romiplostim for the treatment of thrombocytopenic purpura

NICE recommends romiplostim for the treatment of rare blood disorder.

Guidance1. Romiplostim is recommended for the treatment of adults with chronic immune (idiopathic) thrombocytopenia purpura:

whose condition is refractory to standard active treatments and rescue therapies or

who have severe disease and a high risk of bleeding that needs frequent courses of rescue therapies and

if the manufacturer makes romiplostim available with the discount agreed as part of the patient access scheme.

2. Only a haematologist should start and supervise treatment with romiplostim.

The Scottish Medicines Consortium (SMC) published a Statement of Advice (553/09) on this medication for this indication in October 2009. This stated that:

Advice following a full submission

romiplostim (Nplate) is accepted for restricted use within NHS Scotland for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Romiplostim is also accepted for restricted use as second line treatment for adult non-splenectomised patients where surgery is contra-indicated. Romiplostim is restricted to use in patients with severe symptomatic ITP or patients with a high risk of bleeding.

Romiplostim was significantly better than placebo in maintaining platelets at (or above) a minimum target level in previously treated patients with ITP.

Access the advice of the Scottish Medicines Consortium

There is no material difference between the recommendations of the NICE STA and the SMC. The NICE STA advice is based upon the application of a Department of Health agreed Patient Access Scheme.

Note: Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland

NICE Single Technology Appraisal Guidance No 222 – Trabectedin for the treatment of relapsed ovarian cancer

NICE does not recommend trabectedin taken with PLDH (which is short for pegylated liposomal doxorubicin hydrochloride) for women with relapsed platinum-sensitive ovarian cancer.

Guidance

Trabectedin in combination with pegylated liposomal doxorubicin hydrochloride (PLDH) is not recommended for the treatment of women with relapsed platinum-sensitive ovarian cancer.

Women with relapsed platinum-sensitive ovarian cancer currently receiving trabectedin plus PLDH should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

The Scottish Medicines Consortium (SMC) published a Statement of Advice (634/10) on this medication for this indication in September 2010. This stated that:

Advice following a full submission

trabectedin (Yondelis) is not recommended for use within NHS Scotland.

Indication under review: Trabectedin in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.

In an open-label randomised controlled study trabectedin in combination with PLD was significantly superior to PLD monotherapy in terms of progression free survival. There was a significant difference in an exploratory interim analysis of overall survival in the sub-group of patients with partially platinum-sensitive disease.

The manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC and in addition, the manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC.

Access the advice of the Scottish Medicines Consortium

There is no material difference between the recommendations of the NICE STA and the SMC.

Note: Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.